A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

Primary Objective:
To assess the long-term safety of vatelizumab in MS patients
Secondary Objective:
To assess the long-term efficacy of vatelizumab

开始日期2015-02-01

申办/合作机构

Genzyme Corp.

NCT02222948

/ Terminated临床2期

A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Primary Objectives:
To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients.
To evaluate multiple doses of vatelizumab for a dose-response.
Secondary Objectives:
To evaluate the safety and tolerability of vatelizumab compared to placebo.
To evaluate the pharmacokinetics (PK) of vatelizumab.

开始日期2014-09-01

申办/合作机构

Genzyme Corp.

NCT01861249

/ Terminated临床2期

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Primary Objective:
To assess the long term safety and tolerability of SAR339658
Secondary Objective:
To assess the long term efficacy of SAR339658

开始日期2013-07-01

申办/合作机构

Sanofi

100 项与 Vatelizumab 相关的临床结果

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100 项与 Vatelizumab 相关的转化医学

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100 项与 Vatelizumab 相关的专利（医药）

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项与 Vatelizumab 相关的文献（医药）

2019-05-21·International immunology3区 · 医学

VLA-2 blockade in vivo by vatelizumab induces CD4+FoxP3+ regulatory T cells

3区 · 医学

Article

作者: Herich, Sebastian ; Breuer, Johanna ; Rakhade, Sanjay ; Ostkamp, Patrick ; Schneider-Hohendorf, Tilman ; Schwab, Nicholas ; Wiendl, Heinz ; Antonijevic, Irina ; Klotz, Luisa

Abstract:

Integrin α2β1, also known as very late antigen (VLA)-2, is a collagen-binding molecule expressed constitutively on platelets. Vatelizumab, a monoclonal antibody targeting the α2 subunit (CD49b) of VLA-2, was recently investigated for its safety and efficacy during a Phase 2 clinical study in multiple sclerosis patients, as integrin-mediated collagen binding at the site of inflammation is central to a number of downstream pro-inflammatory events. In the course of this study, we could show that VLA-2 is expressed ex vivo on platelets, platelet–T-cell aggregates, as well as a small population of highly activated memory T cells. Even though the clinical trial did not meet its primary clinical end-point (reduction in the cumulative number of new contrast-enhancing lesions on magnetic resonance imaging (MRI)), we observed enhanced frequencies of regulatory T cells (TREG) following vatelizumab treatment. Elevated TREG frequencies might be explained by the inhibition of p38 mitogen-activated protein kinase (MAPK) signaling, which is critically involved in the polarization of T helper 17 (TH17) cells and is activated by the α2 integrin cytoplasmic domain. Our findings suggest that blockade of VLA-2 might be a way to safely shift the TH17/TREG balance by inducing TREGin vivo.

2015-07-03·Expert opinion on investigational drugs2区 · 医学

Inflammatory bowel disease therapies discontinued between 2009 and 2014

2区 · 医学

Review

作者: Mozaffari, Shilan ; Nikfar, Shekoufeh ; Abdollahi, Mohammad

INTRODUCTION:

New therapeutic approaches are currently under development, which consider the fundamental mechanisms involved in the pathogenesis of inflammatory bowel disease (IBD). The disease is associated with inflamed intestinal and colonic mucosa in response to the dysregulated immune system.

AREAS COVERED:

The aim of this article is to review drugs that have been designed for the treatment of IBD and discontinued between 2009 and 2014. Herein, nine molecules with different mechanisms of action are under review. Brodalumab, daclizumab, elubrixin and vatelizumab were withdrawn from the Phase II trial due to the lack of efficacy. Abatacept was not significantly superior to the placebo in the rate of remission and its Phase III trials were stopped. CNDO-210 and Catridecacog were discontinued due to safety concerns and lack of efficacy, respectively. Finally, NU-206 and alkaline phosphatase also ceased in development during Phase I and II tests.

EXPERT OPINION:

The development in our knowledge and understanding of the pathophysiology of IBD and the identification of key objectives for the future play significant roles in IBD therapeutic development. Furthermore, well-planned clinical trials with concise measures of efficacy and safety are required to better decide whether to extend or terminate the development process. Some anti-inflammatory cytokines such as IL-2, IL-12, IL-17, IL-18, IL-23 and INF-γ could garner more attention in the future.

项与 Vatelizumab 相关的新闻（医药）

2015-10-30

·BioSpace

Sanofi Walks Away from a $613 Million Multiple Sclerosis Pact with Glenmark Pharma

October 30, 2015 By Alex Keown , BioSpace.com Breaking News Staff PARIS – After experimental multiple sclerosis drug vatelizumab failed to meet its primary endpoints in a mid-stage trial, Sanofi AG said it has dropped plans to develop the drug with India-based Glenmark Pharmaceuticals . During a second-quarter results analysis with media members, Glenmark revealed that Sanofi was terminating the development agreement for vatelizumab, also known as GBR 500, the Press Trust of India reported. Glenmark said it will look for a new partnership to develop the drug. Vatelizumab is being developed for the treatment of relapsing-remitting multiple sclerosis. Vatelizumab is a monoclonal antibody that targets VLA-2, a collagen-binding integrin expressed on activated lymphocytes. Although its mechanism of action is not known, Sanofi said at the time it was enrolling patients in a Phase II trial, that it believed the drug would “block VLA-2 on activated immune cells, leading to interference with collagen-binding in areas of inflammation, and thus may reduce the inflammatory cascade in MS.” Sanofi struck a development deal with Glenmark in 2011 for up to $613 million. So far, Glenmark has only received about $55 million from Sanofi . The remaining payments were to be made as the drug got closer to regulatory approval. Under the terms of the deal, Sanofi was to have marketing rights for products developed using GBR 500 in North America, Europe, Japan, Argentina, Chile and Uruguay. Sanofi and Glenmark had a deal to co-market any products in Russia, Brazil, Australia and New Zealand, the Press Trust reported. According to a recent report on MS therapeutics by GBI Research , the global market for MS treatments is expected to hit $17.9 billion by 2019. GBI expects a number of new drugs and monoclonal antibodies (mAbs) to hit the market in the next couple years. Numerous drug companies are working on treatments for multiple sclerosis, including Genentech , which is planning to seek regulatory approval for its multiple sclerosis treatment ocrelizumab sometime next year, the company said . There are currently a number of treatments on the market, including Teva Neuroscience ’s Copaxone, which had global sales in 2012 of $4 billion. Other drugs include Novartis ’ Gilenya and Biogen, Inc. ‘s Tecfidera. Biogen ’s drug has received some negative press after Dutch doctors published a report in the “ New England Journal of Medicine ” saying more cases of brain infections may occur in patients taking drugs similar to the company’s top multiple sclerosis treatment. In their report, the doctors noted that patients who take dimethyl fumarate, which Biogen markets as Tecfidera, are at “risk for opportunistic infections, ” including progress multifocal leukoencephalopathy (PML), which may initially present as new or worsening weakness in the body. In addition to its MS drug, Glenmark is developing treatments for cancer, autoimmune diseases and chronic pain.Multiple sclerosis is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around the nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage, which can cause a wide range of symptoms, including muscle weakness, fatigue, difficulty seeing, and may eventually lead to disability.

临床2期引进/卖出上市批准

2014-09-11

·BioSpace

Sanofi Aims For M&A With Genzyme

September 11, 2014 By Mark Terry , BioSpace.com Breaking News Staff The head of Genzyme ‘s multiple sclerosis (MS) unit, Bill Sibold , recently indicated that the company is “very active” in looking for companies to acquire to bolster is MS franchise. Genzyme, a rare drug unit of Sanofi , just announced positive interim results from the second year of an extension of study of its multiple sclerosis drug Lemtrada (alemtuzumab). Lemtrada is sold in Europe and was approved in the U.S in December 2014. The Phase III trials of Lemtrada were randomized, two-year pivotal studies that compared treatment with Lemtrada to treatment with high-dose subcutaneous interferon beta-1a (Rebif). The patients involved had relapsing-remitting MS who were either newly diagnosed or had relapsed after prior therapy. The study found relapse rates and sustained accumulation of disability remained low. Genzyme also has another MS drug, Aubagio, which was approved by the FDA two years ago. Genzyme President and CEO David Meeker recently noted that, “Between clinical trials and commercial use in more than 40 countries, approximately 30,000 patients have now been treated with Aubagio. With Lemtrada, we have also made significant progress with approvals in more than 30 countries.” Genzyme is currently presenting data regarding its MS pipeline at the 30th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), being held in Boston from Sept. 10-13. Other MS pipeline studies include Vatelizumab, in partnership with Glenmark Pharmaceuticals ;GZ402668, currently in Phase I clinical development; R&D programs looking at drugs that promote remyelination; and collaborations with Brigham and Women’s Hospital and the Cleveland Clinic . Although Genzyme, and as a result, Sanofi, are doing well with MS product organic growth, the company is also looking for potential acquisition targets to bolster external growth. Sibold declined to cite potential targets, but indicated they were looking for companies with truly innovative products. Sibold, when asked what his budget for acquisitions was, indicated that being a part of pharmaceutical giant Sanofi made that much easier. “If the opportunity is the right opportunity, we’ll evaluate it,” he said. “We’re well resourced to execute our strategy.” Genzyme was acquired by Sanofi in 2011 for $20.1 billion. Analysts expect Aubagio to achieve about $1.2 billion in sales by 2018, significantly higher than their predictions for Lemtrada of $437 million. In its Q2 2014 financial reports , Sanofi announced group sales rose by 6.4 percent to €8,075 million, driven by Genzyme, with an increase of 29.1 percent. Sales grew 27.3 percent (to €235 million) in the U.S., 47.3 percent (to €144 million) in Emerging Markets and 22.9 percent (to €209 million) in Western Europe. First-half sales of Genzyme increased by 25.4 percent to €1,209 million. var switchTo5x=true; stLight.options({publisher: "0341611e-38a4-415d-9e18-75e093ff27e0", doNotHash: false, doNotCopy: false, hashAddressBar: false});

临床结果上市批准并购临床1期临床3期

2006-09-25

·BioSpace

Chromos Molecular Systems Inc. Announces Changes To Its Board Of Directors

BURNABY, BC, Sept. 22 /PRNewswire-FirstCall/ - Chromos Molecular Systems Inc. today announced that Dr. James Miller and Mr. Ronald MacKenzie have resigned from its Board of Directors, effective immediately. Chromos is currently in discussions with various groups, included those affiliated with Dr. Miller and Mr. MacKenzie, regarding additional financing. Acting on advice from their respective legal counsel, Dr. Miller and Mr. MacKenzie indicated that they have tendered their resignations as directors to avoid any potential conflict of interest in financing discussions. These resignations bring the number of directors on the Board to four. In its Management's Discussion and Analysis of Financial Condition and Results of Operations for the second quarter ended June 30, 2006, Chromos reported that its funds on hand and anticipated revenues from existing licensing contracts would be sufficient to fund its operations into the fourth quarter of 2006. There can be no assurance that additional financing will be available at all or on acceptable terms to permit the Company's current operations to continue. Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The Company's lead program, CHR-1103, is a humanized monoclonal antibody being developed as a treatment for acute relapses associated with multiple sclerosis. Chromos generates revenue from its proprietary ACE System technology to engineer production quality cell lines to manufacture biopharmaceutical products including monoclonal antibodies. For more information visit our website at . Risks and Uncertainties Certain of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Chromos (the "Company"), or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with the Company's operations. Operating risks include (i) the continued availability of capital to finance the Company's activities; (ii) the Company's limited cash position, (iii) the ability to successfully obtain proof of the effectiveness of the Company's technology (iv) the ability to complete and maintain corporate alliances relating to the development and commercialization of the Company's technology; (v) the ability to obtain and enforce patent and other intellectual property protection for the Company's technology; (vi) market acceptance of the Company's technology; (vii) the competitive environment and impact of technological change; (viii) the Company's ability to attract and retain employees to carry out its business plans and (ix) the timely development and commercialization of any technology or products that are contingent on the completion and maintenance of corporate alliances with third parties. Further details on Chromos' operating risks can be found in the Company's Quarterly and Annual Reports to Shareholders. Chromos is a registered trademark of Chromos Molecular Systems Inc. CONTACT: Jeff Charpentier, Vice President, Finance and Chief Financial Officer, Tel: (604) 415-7132, Email:jcharpentier@chromos.com, Website: Chromos Molecular Systems Inc. CONTACT: Jeff Charpentier, Vice President, Finance and Chief FinancialOfficer, Tel: (604) 415-7132, Email:jcharpentier@chromos.com, Website:

抗体高管变更

100 项与 Vatelizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Vatelizumab	-	DB12346

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发-缓解型多发性硬化	临床2期	美国	Genzyme Corp.	2014-09-01
复发-缓解型多发性硬化	临床2期	加拿大	Genzyme Corp.	2014-09-01
复发-缓解型多发性硬化	临床2期	波兰	Genzyme Corp.	2014-09-01
复发-缓解型多发性硬化	临床2期	俄罗斯	Genzyme Corp.	2014-09-01
复发-缓解型多发性硬化	临床2期	瑞典	Genzyme Corp.	2014-09-01
溃疡性结肠炎	临床2期	美国	Sanofi	2012-08-01
溃疡性结肠炎	临床2期	奥地利	Sanofi	2012-08-01
溃疡性结肠炎	临床2期	加拿大	Sanofi	2012-08-01
溃疡性结肠炎	临床2期	法国	Sanofi	2012-08-01
溃疡性结肠炎	临床2期	德国	Sanofi	2012-08-01